The present invention is directed to a sterilization challenge specimen holder. More particularly, the present invention pertains to a reusable specimen holder for challenge in a sterilization environment.
The sterilization of medical equipment, towels (for hospital and operating room use), gowns and the like is carried out, for the most part, using steam sterilization equipment and methods. For example, a bundle of towels is placed into a steam sterilizer, a vacuum is drawn in the sterilizer to evacuate the air, and steam is introduced to sterilize the bundle of towels.
Due to the nature of the towels being “bundled” it may be difficult to assure that the innermost regions (volume) of the towels have been sufficiently subjected to the steam (time and temperature) to assure proper levels of sterilization. Essentially, it is a “challenge” for the steam to be introduced to the innermost parts to effect sterilization.
To this end, “challenge packs” or “challenge kits” have been created to simulate the bundle and more specifically to simulate the difficulty or resistance in reaching the innermost parts: (1) to effect a vacuum; and (2) to introduce steam sufficient to sterilize the local area. There is in fact an ANSI standard for challenge packs that is based upon a bundle of towels having a specific size.
Presently, there are challenge packs on the market. These include paper stacks (stacked like a deck of cards) with an indicator sheet generally in the middle of the stack that can indicate either that a vacuum has been achieved or that a sufficient amount of steam has reached the indicator pack. Another includes a paper stack with a cut out center with a biological indicator vile in the middle. Still another type of indicator includes a plastic tube that has a hole in one end, is packed with a permeable material (such as a towel or absorbent paper sheet) and an indicator at the opposite end.
All of these challenge packs are one time use, disposable products. Various indicators (e.g., for use in the middle of the stack or for other types of uses) can be used in different environments and situations and provide indication of vacuum, biological activity (or inactivity) or steam contact.
Accordingly, there is a need for a challenge device that provide sufficient challenge to sterilization on a consistent basis. Desirably, such a device is easy to use and does not require additional packing materials (towel bundles). More desirably, such a device is reusable with disposable (one-time use) indicators. Most desirably such a device is a passive device (e.g., no moving mechanical and/or electro-mechanical components).